§Patients were initially treated with parenteral anticoagulation in both treatment arms (ximelagatran had previously been shown to have a higher early rate of recurrent VTE compared to warfarin and enoxaparin).

§Dabigatran non inferiror to warfarin in terms of the primary outcome (recurrence of VTE at 6 months)

§3% of patients on dabigatran had dyspepsia

% at 6 months

Warfarin

Dabigatran

Recurrent VTE

2.1

2.4

Major bleeding

1.9

1.6

Non-Major bleeding

8.8

5.6 (P=0.002)

Adverse event leading to discontinuation of the drug

6.8

9.0 (P=0.05)

Rivaroxaban and Apixaban

§Factor Xa inhibitors (NB not direct thrombin inhibitors)

§Rivaraoxaban – excretion mainly renal

§Apixaban – excretion mainly fecal

§Phase III development

§RECORD trials for rivaroxaban post THR and TKR showed no inferiority compared to enoxaparin and no increase in bleeding rates.

§Phase III studies for rivaraxoaban and apixaban for treatment of VTE and stroke prevention in AF are on-going